Trials / Completed
CompletedNCT02224677
Craniofacial Microsomia: Longitudinal Outcomes in Children Pre-Kindergarten (CLOCK)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 417 (actual)
- Sponsor
- Seattle Children's Hospital · Academic / Other
- Sex
- All
- Age
- 12 Months – 24 Months
- Healthy volunteers
- Not accepted
Summary
This study is a multi-center, longitudinal cohort study of 125 infants with craniofacial microsomia (CFM) and 100 infants without craniofacial anomalies. Participants will undergo a series of evaluations between 0-3 years of age to comprehensively evaluate the developmental status of infants and toddlers with CFM. This research design will also explore specific pathways by which CFM may lead to certain outcomes. Specifically, the study explores (1) the longitudinal relations between facial asymmetry and emotion-related facial movements and socialization; and (2) associations among ear malformations, hearing and speech deficits and cognitive outcomes. Results of this research will ultimately lead to future investigations that assess new interventions and corresponding changes in current standards of care for children with CFM.
Conditions
- Craniofacial Microsomia
- Hemifacial Microsomia
- Oculo-Auriculo-Vertebral-Syndrome
- Goldenhar Syndrome
- Microtia
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2019-08-31
- Completion
- 2019-08-31
- First posted
- 2014-08-25
- Last updated
- 2024-04-19
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02224677. Inclusion in this directory is not an endorsement.